A Phase 2 Multicenter, Randomized, Double-blinded, Study to Describe the Safety, Efficacy, and Pharmacokinetics of Daptomycin 10 mg/kg/Day and Vancomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations
研究概览
简要总结
The overall goals of this study are to compare the safety and efficacy of daptomycin monotherapy 10 mg/kg/day and vancomycin monotherapy dosed to achieve vancomycin trough levels of 15 to 20 μg/mL for the treatment of methicillin-resistant S. aureus bacteremia (MRSA), including right-sided infective endocarditis (RIE).
详细描述
Patients who meet all inclusion criteria and exhibit none of the exclusion criterial will be randomized to one of two treatment arms:
- daptomycin Intravenously (IV) 10 mg/kg every 24 hours
- vancomycin IV dosed to maintain trough levels of 15 to 20 μg/mL.
The suggested duration of therapy with daptomycin or vancomycin will be 28 days (or up to 42 days if clinically indicated). Dose adjustments for both drugs will be made by an unblinded pharmacist at each site. To minimize the duration with which patients are treated with antibacterial agents effective against S. aureus prior to enrollment, patients with suspected MRSA bacteremia will be enrolled pending definitive culture results. Suspected MRSA bacteremia will be defined clinically or as initial blood cultures that grow Gram-positive cocci and that were obtained from a patient at increased risk for methicillin-resistant S. aureus infections. However, only patients with confirmed MRSA bacteremia or right-sided infective endocarditis will remain in the study and be evaluated for efficacy. During treatment, regular assessments will be performed. An End-of Therapy (EOT) will be performed 1-3 days after stopping therapy or upon Early Termination (ET). All patients will have a post therapy visit for Test of Cure (TOC) performed 35-49 days following last dose of study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
daptomycin 10 mg/kg
Daptomycin 10 mg/kg IV every 24 hours
干预措施: daptomycin (Drug)
vancomycin high-dose
Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
干预措施: vancomycin (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations
时间窗: On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days)
Number of participants with treatment-emergent CPK elevations ≥5 x upper limit of normal (≥1,000 U/L) by the EOT visit.
Number of Participants With Elevated Serum Creatinine
时间窗: On therapy and up to 3 days post-therapy (treatment duration ranged from 2 to 43 days)
Number of participants with treatment-emergent serum creatinine increases ≥0.5 mg/dL (for patients with a baseline value ≤3.0 mg/dL) or ≥1.0 mg/dL (for patients with a baseline value \>3.0 mg/dL) by the EOT visit.
次要结局
- Number of Participants With Treatment Cure at Test of Cure (TOC)/Safety Visit(Test of Cure (TOC) Visit (35 to 49 days post-therapy, approximately week 8))
- Number of Participants With Treatment Cure at End of Therapy (EOT) Visit(End of Therapy (median day 12 and 6.5 in daptomycin and vancomycin modified intent-to treat population, respectively))